{
    "info": {
        "nct_id": "NCT01955473",
        "official_title": "A Japanese Phase I Open-label Dose-escalation Trial of Sym004 Administered as Monotherapy in Japanese Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "* Japanese male or female subjects aged greater than or equal to 20 years at the time of informed consent signature\n* Histologically or cytologically confirmed cancer\n* Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy of at least 3 months\n* Written informed consent given before any trial-related activities are carried out\n* Other protocol defined inclusion criteria could apply\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Subjects with symptomatic brain metastases\n* Subjects who received total resection or irradiation of the target lesion\n* Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent\n* Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1\n* Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)\n* Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)\n* Magnesium of less than 0.9 milligram per deciliter (mg/dL)\n* Abnormal organ or bone marrow function as defined in the protocol\n* Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1\n* Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator\n* Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components\n* Clinically significant cardiac disease or concurrent, uncontrolled medical condition\n* Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies\n* Other protocol defined exclusion criteria could apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Japanese male or female subjects aged greater than or equal to 20 years at the time of informed consent signature",
                "criterions": [
                    {
                        "exact_snippets": "Japanese male or female subjects",
                        "criterion": "ethnicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "Japanese"
                        }
                    },
                    {
                        "exact_snippets": "male or female subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "aged greater than or equal to 20 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Japanese male or female subjects",
                        "criterion": "ethnicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "Japanese"
                        }
                    },
                    {
                        "exact_snippets": "male or female subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "aged greater than or equal to 20 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed cancer",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy)",
                "criterions": [
                    {
                        "exact_snippets": "Refractory or recurrent advanced late stage solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced late stage"
                        }
                    },
                    {
                        "exact_snippets": "Refractory or recurrent advanced late stage solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": [
                                "refractory",
                                "recurrent"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "without available therapeutic options which are likely to provide patient benefit",
                        "criterion": "therapeutic options",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "failure and/or intolerance to standard anti-cancer therapy",
                        "criterion": "standard anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "failure",
                                "intolerance"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Refractory or recurrent advanced late stage solid tumors",
                                        "criterion": "solid tumors",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "advanced late stage"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Refractory or recurrent advanced late stage solid tumors",
                                        "criterion": "solid tumors",
                                        "requirement": {
                                            "requirement_type": "condition",
                                            "expected_value": [
                                                "refractory",
                                                "recurrent"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "without available therapeutic options which are likely to provide patient benefit",
                                "criterion": "therapeutic options",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "failure and/or intolerance to standard anti-cancer therapy",
                        "criterion": "standard anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "failure",
                                "intolerance"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy of at least 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Written informed consent given before any trial-related activities are carried out",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written informed consent given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other protocol defined inclusion criteria could apply",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol defined inclusion criteria",
                        "criterion": "protocol defined inclusion criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other protocol defined inclusion criteria",
                        "criterion": "protocol defined inclusion criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 20 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects with symptomatic brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "symptomatic brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirement": {
                        "requirement_type": "symptom presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects who received total resection or irradiation of the target lesion",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who received total resection",
                        "criterion": "target lesion resection",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "total resection"
                        }
                    },
                    {
                        "exact_snippets": "Subjects who received ... irradiation of the target lesion",
                        "criterion": "target lesion irradiation",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "irradiation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Subjects who received total resection",
                        "criterion": "target lesion resection",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "total resection"
                        }
                    },
                    {
                        "exact_snippets": "Subjects who received ... irradiation of the target lesion",
                        "criterion": "target lesion irradiation",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "irradiation"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent",
                "criterions": [
                    {
                        "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy",
                        "criterion": "cytotoxic or cytostatic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... antibody therapy",
                        "criterion": "antibody therapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... tyrosine kinase inhibitors",
                        "criterion": "tyrosine kinase inhibitors",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... any investigational agent",
                        "criterion": "investigational agent",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy",
                                "criterion": "cytotoxic or cytostatic anti-cancer therapy",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... antibody therapy",
                                "criterion": "antibody therapy",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... tyrosine kinase inhibitors",
                                "criterion": "tyrosine kinase inhibitors",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: ... any investigational agent",
                                "criterion": "investigational agent",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1",
                "criterions": [
                    {
                        "exact_snippets": "Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004",
                        "criterion": "vaccine therapy as anticancer treatment",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004",
                    "criterion": "vaccine therapy as anticancer treatment",
                    "requirement": {
                        "requirement_type": "time since last administration",
                        "expected_value": {
                            "operator": "<=",
                            "value": 12,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)",
                "criterions": [
                    {
                        "exact_snippets": "Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)",
                "criterions": [
                    {
                        "exact_snippets": "Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)",
                        "criterion": "skin manifestation",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE v4.03)"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)",
                        "criterion": "skin manifestation",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE v4.03)"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Magnesium of less than 0.9 milligram per deciliter (mg/dL)",
                "criterions": [
                    {
                        "exact_snippets": "Magnesium of less than 0.9 milligram per deciliter (mg/dL)",
                        "criterion": "magnesium level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.9,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Magnesium of less than 0.9 milligram per deciliter (mg/dL)",
                        "criterion": "magnesium level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.9,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Abnormal organ or bone marrow function as defined in the protocol",
                "criterions": [
                    {
                        "exact_snippets": "Abnormal organ or bone marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "abnormal"
                        }
                    },
                    {
                        "exact_snippets": "Abnormal organ or bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "abnormal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Abnormal organ or bone marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "abnormal"
                        }
                    },
                    {
                        "exact_snippets": "Abnormal organ or bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "abnormal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1",
                "criterions": [
                    {
                        "exact_snippets": "Received immunosuppressive agents",
                        "criterion": "immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mg/day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks before the first administration of Sym004 at Week 1",
                        "criterion": "time since last administration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received immunosuppressive agents",
                                "criterion": "immunosuppressive agents",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within 4 weeks before the first administration of Sym004 at Week 1",
                                "criterion": "time since last administration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent",
                                "criterion": "systemic corticosteroids",
                                "requirement": {
                                    "requirement_type": "dose",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 20,
                                        "unit": "mg/day"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "within 4 weeks before the first administration of Sym004 at Week 1",
                                "criterion": "time since last administration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator",
                "criterions": [
                    {
                        "exact_snippets": "Active severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Active severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any other concurrent disease or medical conditions",
                        "criterion": "concurrent disease or medical conditions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "deemed to interfere with the conduct of the trial as judged by the Investigator",
                        "criterion": "interference with the conduct of the trial",
                        "requirement": {
                            "requirement_type": "judgement",
                            "expected_value": "Investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Active severe infection",
                                        "criterion": "infection",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "severe"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Active severe infection",
                                        "criterion": "infection",
                                        "requirement": {
                                            "requirement_type": "activity",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "any other concurrent disease or medical conditions",
                                        "criterion": "concurrent disease or medical conditions",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "deemed to interfere with the conduct of the trial as judged by the Investigator",
                                        "criterion": "interference with the conduct of the trial",
                                        "requirement": {
                                            "requirement_type": "judgement",
                                            "expected_value": "Investigator"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components",
                "criterions": [
                    {
                        "exact_snippets": "Known human immunodeficiency virus (HIV) positive",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active Hepatitis B or C",
                        "criterion": "Hepatitis B or C status",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled allergic conditions",
                        "criterion": "allergic conditions",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "allergy to Sym004 or its components",
                        "criterion": "allergy to Sym004 or its components",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known human immunodeficiency virus (HIV) positive",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active Hepatitis B or C",
                        "criterion": "Hepatitis B or C status",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "uncontrolled allergic conditions",
                                "criterion": "allergic conditions",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrolled"
                                }
                            },
                            {
                                "exact_snippets": "allergy to Sym004 or its components",
                                "criterion": "allergy to Sym004 or its components",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant cardiac disease or concurrent, uncontrolled medical condition",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "concurrent, uncontrolled medical condition",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Clinically significant cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "concurrent, uncontrolled medical condition",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies",
                "criterions": [
                    {
                        "exact_snippets": "Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies",
                        "criterion": "infusion-related reactions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies",
                        "criterion": "infusion-related reactions",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": "chimeric monoclonal antibodies"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies",
                                "criterion": "infusion-related reactions",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "Grade"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "Grade"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies",
                                "criterion": "infusion-related reactions",
                                "requirement": {
                                    "requirement_type": "association",
                                    "expected_value": "chimeric monoclonal antibodies"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other protocol defined exclusion criteria could apply",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol defined exclusion criteria",
                        "criterion": "protocol defined exclusion criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other protocol defined exclusion criteria",
                    "criterion": "protocol defined exclusion criteria",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}